APPRAISE-HRI
FDA 510(k) clearance K233249 · decided 2024-04-05
Clearance details
- K-number
- K233249
- Device name
- APPRAISE-HRI
- Applicant
- The Surgeon General, Department of the Army (TSG-DA)
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2024-04-05
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- SAR
- Device class
- 2
- Regulation number
- 870.2220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fort Dietrick, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.